Long-Term Treatment Effect of DiaPep277 in Type 1 Diabetes
- Registration Number
- NCT00644501
- Lead Sponsor
- Andromeda Biotech Ltd.
- Brief Summary
The study is an open-label extension study, offering patients who participated and completed previous study 901 to continue treatment with DiaPep277 and clinical follow-up, for 2 additional years. The expectation is first to demonstrate that extended treatment with DiaPep277 is safe and second to evaluate the long-term effectiveness of treatment. Only patients who completed the previous 2-year study and still have beta-cell function above a threshold level will be eligible for this extension study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
Inclusion Criteria
- A patient that participated in previous 461/PO and 901 studies and received all doses of study medication, per protocol.
- Evidence of clinically significant residual beta-cell function demonstrated by MMTT stimulated C-peptide concentrations ≥ 0.20 nmol/L.
Exclusion Criteria
- The patient is pregnant or intends to become pregnant or is unwilling to use effective contraceptive method throughout the study.
- The subject has clinical evidence of any diabetes-related complication, or severe allergy or immune deficiency.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 DiaPep277 -
- Primary Outcome Measures
Name Time Method Preservation of endogenous insulin secretion/beta-cell function, as measured by mixed-meal tolerance test stimulated C-peptide secretion. every 6 months up to 24 months from T0
- Secondary Outcome Measures
Name Time Method improved metabolic control and the insulin dose required to maintain it. every 3 months up to 24 months from T0
Trial Locations
- Locations (3)
Diabetic Unit, Hadassah Medical Center
🇮🇱Jerusalem, Israel
Schneider Children's Medical Centre
🇮🇱Petach Tikva, Israel
Wolfson Medical Centre
🇮🇱Holon, Israel